Guanfacine in Children With Tic Disorders

Tourette Syndrome Clinical Trial

Official title:

Guanfacine in Children With Tic Disorders: A Multi-site Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547000
• Other study ID #: 1004006635
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Description:

Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.

• Between ages 6 yrs 0 mos and 17 years 0 months.

• Weight >/= 15 kg (33 lbs).

• Ability to swallow pills whole.

Exclusion Criteria:

• IQ < 80.

• Positive pregnancy test.

• Positive drug test.

• Low blood pressure.

• Prior history of hypersensitivity to guanfacine.

• Prior failed treatment with an adequate trial of guanfacine in last 2 years.

• Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy.

• Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.

Related Conditions & MeSH terms

• Disease
• Tic Disorders
• Tics
• Tourette Disorder
• Tourette Syndrome

Intervention

Drug:
• placebo
Administered up to 8 weeks.
• extended-release guanfacine (Intuniv)
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York
United States	University of South Florida	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Icahn School of Medicine at Mount Sinai, New York University, Shire, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale (YGTSS)	The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.	8 weeks